NCT07790276尚未招募不适用
Glycemic Assessment Based on Continuous Glucose Monitoring and Clinical Outcomes in People With Diabetes on Peritoneal Dialysis: a Multi-centered Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Elaine Chow
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Continuous glucose monitoring-derived metrics
研究概览
简要总结
This prospective, multicenter observational study will evaluate glucose profiles using continuous glucose monitoring (CGM) in 100 adults with diabetes receiving peritoneal dialysis (PD) or planning to start PD within 3 months. The study will examine associations between CGM metrics and PD regimen, glucose-lowering treatment, conventional glycemic markers, dialysis-related measures, and clinical outcomes including glycemic emergencies, hospitalizations, cardiovascular events, and mortality over 12 months.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Stage 5 CKD patients
- who have received PD for at least 3 months, OR
- who are planned for PD within the next 3 months.
- Age 18-80 years old
- Known history of type 1 or type 2 diabetes for at least 3 months
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
- Willingness to abstain from swimming during their participation in the measurement phase.
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
- Written informed consent to participate in the study provided by the patient.
排除标准
- Patients who are planning to switch to hemodialysis or renal transplant in the coming 3 months
- Life expectancy <6 months
- Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites
- HbA1c > 11% at enrolment
- Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential.
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- Have a known allergy to medical-grade adhesives or known hypersensitivity to any of the products used in the study.
- Have MRI scan, CT scan, or diathermy scheduled during the proposed period of sensor wearing during the study
研究组 & 干预措施
peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who have been receiving peritoneal dialysis for at least 3 months at enrollment.
干预措施: Continuous glucose monitoring system (Device)
pre-peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who are planned to initiate peritoneal dialysis within 3 months after enrollment.
干预措施: Continuous glucose monitoring system (Device)
结局指标
主要结局
Continuous glucose monitoring-derived metrics
时间窗: During period of 14 day CGM wear
CGM derived time in ranges
次要结局
- HbA1c(Baseline to end of study period month 12)
- CGM user satisfaction(Baseline and month 3)
- Health-related quality of life(Baseline)
- Quality of life specific to kidney disease(Baseline)
- 24-hour dialysate and ultrafiltration volume(Baseline through to month 12)
- Residual renal function(From baseline through 12 months)
- Hospitalization for hyperglycemic or hypoglycemic emergencies(From baseline through 12 months)
- Hospitalizations, cardiovascular events, and all-cause mortality(From baseline through 12 months)
- Dietary intake during CGM wear(During the 14-day CGM wear period)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07790276
- 其他研究编号
- GLANCE-PD
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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